PACE Trial and PACE Trial Protocol

[ukxmrv]

I jotted down these rough notes from that part

((start))

6 minute walk test, i have issues for the 6 minute walk test. Reasonably accurate?

If you come back in a few weeks you have done it before, it's no big deal

who is monitoring the tests, gradulate students, how do they do it

don't give anyone any feedback, don't tell them how they are doing

both x and I will need a guard when we leave because I am going to talk about the PACE

I'm going to talk about the only objective test ... the 6 minute walk test

so we saw that there were about 110 people in the treatment arms. The data on the test is based on

51% of the 110 didn't complete the 6 mwt - why?

what can I convert that to that can give us a xx

is this effect large enough to be a meaningful difference

miles per house

2.3 baselines 1.9?

That's sort of walking xx

There are energy cost tables, research tool

called "met" or metabolic metabolism

2 mph equates to 2 mets approx

severely disabled. unlikely to be candidates for a heart transplant as they would be unlikely to survive it

quite likely to be motivation x

 

[Bob]

what can I convert that to that can give us a xx

is this effect large enough to be a meaningful difference

miles per house

2.3 baselines 1.9?

That's sort of walking xx

To help fill in the gaps...

He converted the distance walked, for the 6 minute walking distance test, to a 'speed'.

He calculated the speed to be 1.9 mph at baseline, and 2.3 mph at end of the trial.

He said that's not a fast pace, but it's the sort of speed that someone would amble round an office.

 

[Bob]

Recent study by Knoop and Bleijenberg. (I don't remember seeing it posted on this forum before.)

They've published on this topic before, where they focus only on fatigue, and not on physical disability, assuming that changing perceptions of fatigue is therapeutic for CFS patients.



The role of the therapeutic relationship in cognitive behaviour therapy for chronic fatigue syndrome.
Heins MJ, Knoop H, Bleijenberg G.
Behav Res Ther. 2013 Apr 9;51(7):368-376. doi: 10.1016/j.brat.2013.02.001.
http://www.ncbi.nlm.nih.gov/pubmed/23639303

Abstract
...
Recently, it was found that changes in fatigue-perpetuating factors, i.e. focusing on symptoms, control over fatigue, perceived activity and physical functioning, are associated with and explain up to half of the variance in fatigue during CBT for CFS.
...
A large part of the variance in post-treatment fatigue (25%) was jointly explained by outcome expectations, working alliance and changes in fatigue-perpetuating factors.

 

[Simon]

Er, 25% of the variance explained by three factors is neither large nor impressive, esp as the first two could well lead to self-report bias.

 

[dmbaken]

Hi, our (New Zealand) government is putting together a report on ME/CFS and it looks like they are going to say that CBT and GET are the best treatments. Probably influenced by the NICE Guidelines and the PACE Trial. We would like to present them with some contrary findings before the report is finalised. I thought this might be a good thread to find people who could let us know of any contrary findings.

Thanks in anticipation.

Don

 

[alex3619]

Hi, our (New Zealand) government is putting together a report on ME/CFS and it looks like they are going to say that CBT and GET are the best treatments. Probably influenced by the NICE Guidelines and the PACE Trial. We would like to present them with some contrary findings before the report is finalised. I thought this might be a good thread to find people who could let us know of any contrary findings.

Thanks in anticipation.

Don

dmbaken Have you read the thread? Its long but a lot of issues are covered here relating to this and there are a lot of links. Are there contrary findings? They contradict themselves! Also every study using objective measures has failed to find functional improvement from CBT/GET. The improvement is subjective only, and even then only in an occasional patient, and looks like being mostly due to bias or changes in attitude, not capacity.

It is hard to find specific and clear contrary findings because nobody else (aside from psychiatrists) is doing this. For solid evidence I would start with the research from Stevens and Snell on exercise physiology, which shows a massive decline in energy production. The six minute walking test is probably not valid for ME, so even their not very favourable data is probably biased in their favour.

 

[Shell]

On the self reporting by patients showing change in attitude rather than actual functional improvement; I caught myself at this when talking with the Cardiologist this week. When he asked if symptoms of OI had improved on the new drug, I hesitated. In fact the OI is somewhat worse but I didn't have the heart to tell him that and ended up apologetically admitting things weren't much better.
I realised that partly this is about wanting to seem grateful for the help (I am grateful) but also not wanting the doc to feel like his approach isn't working and being afraid that if I admit it isn't making huge benificial changes that I will be labelled somehow. Part of this is that I am acutely aware that I have dx which make so many docs dismissive. It's a fine line of egg shells we tread with docs.
D'you get what I mean?

 

[alex3619]

I think I understand your point Shell. So many patients probably tell psychiatrists what they want to hear, or something thats kind of like what they want to hear like improved attitude or mood: thats a recognized form of bias. As you have stated, this happens with regular docs too, even cardiologists. We don't want to lose our lifeline, we don't want to disappoint, we don't want to be put in the too hard basket ... it makes things hard for us, particularly if we have lots of cognitive issues at the time. Sometimes its so good to be just doing something even if it does not really help: its empowering, as opposed to the other place.

 

[Valentijn]

Hi, our (New Zealand) government is putting together a report on ME/CFS and it looks like they are going to say that CBT and GET are the best treatments. Probably influenced by the NICE Guidelines and the PACE Trial. We would like to present them with some contrary findings before the report is finalised. I thought this might be a good thread to find people who could let us know of any contrary findings.

Regarding PACE:

• Oxford definition was used to select patients, which only focuses on chronic fatigue. Explicit exclusion of patients in which fatigue was not the primary symptom could have kept out most ME patients (with PEM, pain, OI, etc as most prolific symptom). Hence study results relate to fatigue patients, not ME/CFS patients.
• When comparing to the "control" group (SMC), only something like 13% of the fatigue patients "recovered".
• Recovery was defined to allow for minimal or no improvement among fatigue patients.
• All recovery criteria were subjective - no objective measurements were considered.
• The only objective measurement, the 6 Minute Walking Test, was not used to determine recovery, and showed no statistically significant improvement among patients receiving CBT.
• Adverse events were defined and categorized in a manner to hide and minimize episodes of PEM.
• No objective improvements were shown in physical capacity, work rates, studying, or receipt of public benefits (welfare).

 

[Esther12]

No objective improvements were shown in physical capacity, work rates, studying, or receipt of public benefits (welfare).

Broadly, what PACE shows is that CBT and GET are able to lead to minor improvements in questionnaire scores in a trial which is necessarily unblinded, and with questionable controls. It seems deeply uncertain that CBT and GET are any more helpful for improving disability in CFS patients than a pure placebo like homeopathy would be, and in addition to that, they bring the dangers that occur with the medicalisation of people's cognitions and behaviours. If they are to be promoted as treatments for CFS, it should be argued that they are tightly controlled. In PACE, all treatment sessions were recorded, and if they want to claim that PACE shows these treatments are safe, similar supervision would be required when they adopt these interventions.

Personally, I think it would be best if patients were provided with the resources that would allow them to choose to pay for CBT or GET in the open market if they so wished, rather than having a central organisation claiming that they are helpful for patients when there is so little evidence that this is the case.

There are some summaries of problems with PACE posted here:

http://forums.phoenixrising.me/inde...ques-links-thread-no-discussion-please.14121/

Given the difficulty of defining what 'CFS' is, and who has it, there should be great caution in recommending any treatment to patients just because they have a diagnosis of CFS.

 

[Bob]

Regarding PACE:

• Oxford definition was used to select patients, which only focuses on chronic fatigue. Explicit exclusion of patients in which fatigue was not the primary symptom could have kept out most ME patients (with PEM, pain, OI, etc as most prolific symptom). Hence study results relate to fatigue patients, not ME/CFS patients.
• When comparing to the "control" group (SMC), only something like 13% of the fatigue patients "recovered".
• Recovery was defined to allow for minimal or no improvement among fatigue patients.
• All recovery criteria were subjective - no objective measurements were considered.
• The only objective measurement, the 6 Minute Walking Test, was not used to determine recovery, and showed no statistically significant improvement among patients receiving CBT.
• Adverse events were defined and categorized in a manner to hide and minimize episodes of PEM.
• No objective improvements were shown in physical capacity, work rates, studying, or receipt of public benefits (welfare).

Good summary, Val.
I've taken the liberty of building on it, adding some extra points, and slightly re-wording a couple of your sentences... Let me know if it's OK with you, or not...

• Oxford definition was used to select patients, which only focuses on chronic fatigue. Explicit exclusion of patients in which fatigue was not the primary symptom could have kept out most ME patients (with PEM, pain, OI, etc as most prolific symptom). Hence study results relate to fatigue patients, not ME/CFS patients.
• On average, patients were left with severe disability after treatment with CBT or GET.
• Only approx 13% of patients achieved a minimum level of 'improvement' after treatment with CBT or GET, when using subjective measures, compared with the SMC control group.
• When comparing to the "control" group (SMC), only something like 13% of the fatigue patients "recovered".
• The measure of 'recovery' was a purely research endpoint, which did not indicate either an improvement or a 'recovery' in the lay sense of the word. A 'recovery' could be recorded even if a patient deteriorated after treatment, and had severe impairment or severe disability. Recovery was defined to allow for minimal or no improvement among fatigue patients.
• All 'recovery' criteria were subjective - no objective measurements were considered.
• The only objective disability measurement, the 6 Minute Walking Test, was not used to determine recovery, and showed no statistically significant improvement among patients receiving CBT or GET. On average, patients were left severely disabled after treatment.
• Adverse events were defined and categorized in a manner to hide and minimize episodes of PEM. Deterioration rates, as a measure equivalent to the improvement rates, have not yet been published.
• For the other objective measures used (working hours, private insurance and public welfare benefit claims), there were no significant improvements in any of these measures after treatment with CBT or GET.

 

[Bob]

Broadly, what PACE shows is that CBT and GET are able to lead to minor improvements in questionnaire scores in a trial which is necessarily unblinded, and with questionable controls. It seems deeply uncertain that CBT and GET are any more helpful for improving disability in CFS patients than a pure placebo like homeopathy would be, and in addition to that, they bring the dangers that occur with the medicalisation of people's cognitions and behaviours. If they are to be promoted as treatments for CFS, it should be argued that they are tightly controlled. In PACE, all treatment sessions were recorded, and if they want to claim that PACE shows these treatments are safe, similar supervision would be required when they adopt these interventions.

Good points, Esther.

 

[Mark]

Hi, our (New Zealand) government is putting together a report on ME/CFS and it looks like they are going to say that CBT and GET are the best treatments. Probably influenced by the NICE Guidelines and the PACE Trial. We would like to present them with some contrary findings before the report is finalised. I thought this might be a good thread to find people who could let us know of any contrary findings.

Thanks in anticipation.

Don

It might be worth pointing them at what's happening in the US: in particular, the FDA Workshop for Drug Development has some excellent patient testimony (and some good quotes on the PACE trial and the outdated UK approach). See our article here (part two will be up in a couple of days, and video of the whole workshop is available online). Also there's an analysis of the PACE trial here. The Rituximab research is also worth highlighting. It may be unrealistic to expect NZ to recommend treatments like Ampligen and Rituximab at this stage, but at least that science should help anyone who's not grossly prejudiced to see that real progress is now being made on understanding and treating the immune dysfunction in ME/CFS.

 

[Bob]

Just a brief media quote from Esther Crawley...

Doctory's diary: the less doctors do, the better for everyone
The Daily Telegraph Monday 13 May 2013
http://www.telegraph.co.uk/health/h...-less-doctors-do-the-better-for-everyone.html

With reference to treating CFS in children and adolescents:

"Treatment remains regrettably unsatisfactory, as Dr Esther Crawley, a Reader in child health at Bristol University who organised the study acknowledges, noting the standard regime of graded exercises and cognitive behavioural therapy is only “moderately” effective."






.

 

[Bob]

US journalist wants to speak with people who were on the PACE Trial | 13 May 2013
by Tony Britton on May 14, 2013
A US-based medical journalist researching ME/CFS treatments would like to speak with people who took part in the PACE Trial.
...
http://www.meassociation.org.uk/?p=15449

.

 

[Dolphin]

EAPM2013:1st Annual Scientific Meeting of the European Association of Psychosomatic Medicine - 4- 6 July

Sharpe:

response to PACE very varied and sometimes frankly hostile

This presentation will explore the potential reasons for this response and the implications for the practice of psychological medicine.

After the big long first box, the bits I'm posting are all on the PACE Trial.
~~~~~~~~~~~~~~~~~~~~~~~~

EAPM2013:1st Annual Scientific Meeting of the European Association of Psychosomatic Medicine - 4- 6 July

http://www.eapm2013.com/

The European Association of Psychosomatic Medicine Scientific Meeting (EAPM 2013)

Homerton College Cambridge University Cambridge United Kingdom

Body and Mind: An all age approach to psychosomatic medicine and consultation liaison psychiatry

NEWSFLASH

Don't forget to book your place at the Joint American APM/EAPM Study Day on Wednesday 3 July. Expert speakers including Professor Wayne Katon, Professor Jurgen Unutzer, Professor Michael Sharpe, Professor Christoph Herrmann-Lingen, Professor Simon Gilbody and Dr Carsten Leue will focus on the International perspectives on integrated and collaborative care. Places at this important event are separately bookable from the EAPM meeting and cost £150 plus VAT per head.

Short course programme – five short courses have been timetabled for the morning of Thursday 4 July, prior to the opening of the inaugural Scientific Meeting of EAPM. Each course is facilitated by an expert/s and will be an intensive session – you can choose one of the following topics and register for a place at only £50 plus VAT:

A Somatization Masterclass led by Professor Wayne Katon

B Psychotherapy in medically ill patients led by Sanjeev Sockalingam, University of Toronto

C Psychopharmacology in the medically ill with Professor James Levenson

D Cardiology and neurology course – Dr Zaheer Yousef and Dr Robin Corkill, Cardiff and Vale UHB

E Using Delirium Management Guidelines in general hospitals – Dr Tayyeb Tahir, University Hospital of Wales

http://www.eapm2013.com/scientific-information/

Scientific Information

NATIONAL ORGANISING COMMITTEE

Dr Ben Baig, Clinical Lecturer, King's College, London

Dr Peter Hindley, Consultant Child and Adolescent Psychiatrist, St Thomas' Hospital, London (Chair)

Professor Michael Sharpe, Professor of Psychological Medicine, University of Oxford

Dr Tayyeb Tahir, Consultant Liaison Psychiatrist, Department of Liaison Psychiatry, University Hospital of Wales

Dr Cathy Walsh, Consultant Liaison Psychiatrist, Cambridgeshire and Peterborough NHS Foundation Trust

Dr Emma Weissblatt, Consultant Child and Adolescent Psychiatrist, University College Hospital, London

NATIONAL SCIENTIFIC COMMITTEE

Professor Derek Bolton, MPhil PhD, Professor of Philosophy & Psychopathology
Hon. Consultant Clinical Psychologist,South London & Maudsley NHS Foundation Trust King's College London

Dr Alan Carson,Consultant Neuropsychiatrist, NHS Lothian and University of Edinburgh, Scotland

Dr Gwynneth Down, Joint Head of Psychotherapy – Systemic Psychotherapy,Great Ormond St Hospital for Children Trust, London

Professor Matthew Hotopf, Professor of General Hospital Psychiatry, Institute of Psychiatry, King's College London; Director: Nucleus of SLAM/KCL NIHR Biomedical Research Centre

Professor Allan House, Professor of Liaison Psychiatry, Director, Leeds Institute of Health Sciences

Professor Khalida Ismail, Professor of Psychiatry and Medicine, Institute of Psychiatry, King's College London

INTERNATIONAL COMMITTEE

Dr Alexandre Berney, Consultation Liaison Service, Lausanne University Hospital, Switzerland.

Dr Margarita Beresnevaite, MD PhD, Scientific Worker, Institute of Cardiology of Lithuanian University of Health Sciences, Lithuania

Professor Hans-Christian Deter, Professor of Family Medicine and Psychosomatic Medicine,Medical Clinic, Psychosomatics, Charité Campus Benjamin Franklin, Berlin, Germany

Dr Silvia Ferrari, Psychiatrist, Researcher, University of Modena & Reggio Emilia, Italy

Professor Hongyun Gao, MD & PhD, Director & Professor, Department of Psychological Medicine, Children's Hospital of Fudan University, Shanghai, China

Professor Peter Henningsen, MD, Professor and Head, Dept of Psychosomatic Medicine, University Hospital, Rechts der Isar, Technische Universität München, Germany

Professor Thomas Hyphantis, Associate Professor of Psychiatry, Department of Psychiatry, Medical School, University of Ioannina, Greece

Roger Kathol, President, Cartesian Solutions, Inc.™, USA

Professor Wayne Katon MD, Professor, Vice-Chair, Director of Division of Health Services and Psychiatric Epidemiology, University of Washington Medical School, Seattle, USA

Dr A F G Leentjens, MD, PhD, Senior Lecturer in Neuropsychiatry, Department of Psychiatry, Maastricht University Medical Centre, The Netherlands

Dr Carsten Leue, Psychiatrist, Maastricht University Medical Centre, Netherlands

Professor Ulrik Fredrik Malt, MD PhD, Professor (psychosomatic medicine; psychiatry), Institute of Clinical Medicine, University of Oslo & Director, Dept of Neuropsychiatry and Psychosomatic Medicine; Division of Surgery and Neuroscience, Oslo University hospital-Rikshospitalet

Professor Marta Novak, Associate Professor of Psychiatry, Institute of Behavioral Sciences, Semmelweis University, Budapest, Hungary and Department of Psychiatry, University Health Network, University of Toronto, Toronto, Canada

Dr Charlotte Ulrikka Rask MD PhD, The Research Clinic for Functional Disorders, Aarhus University Hospital
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Dr Wolfgang Soellner, Professor, MD, General Hospital Nuremberg · Psychosomatic Medicine and Psychotherapy,Denmark

Professor Dr Med Gerhard Schüßler, Univ Klinik Medizinische Psychologie, Innsbruck, Austria

Professor Jürgen Unützer, MD, MPH, MA, Professor and Vice Chair, Psychiatry and Behavioral Sciences

Director, Division of Integrated Care and Public Health, Director, UW AIMS Center, Director, IMPACT Implementation Program, Seattle, USA

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EAPM2013: Wow! over 200 abstracts received and counting.....our peer reviewers will be kept busy! 102 days ago

Join the conversation

http://www.eapm2013.com/fullprogramme/

Symposium: Treatment of Chronic Fatigue Syndrome:
Click for Abstract

Recovery from chronic fatigue syndrome after treatments given in the PACE trial Peter D White
Click for Abstract

Cost-effectiveness and cost-utility of treatments given in the PACE trial for chronic fatigue syndrome

Paul McCrone

Click for Abstract

Mechanisms of change underlying the efficacy of cognitive behaviour therapy for chronic fatigue syndrome: a mediation analysis Trudie Chalder

Click for Abstract

What are the lessons for psychological medicine from the PACE trial?

Michael Sharpe

http://www.eapm2013.com/wp-content/uploads/2013/05/236.doc

Abstract 236

Paper 1:
White PD (presenter), Johnson AL, Goldsmith K, Chalder T, Sharpe MC.

Recovery from chronic fatigue syndrome after treatments given in the PACE trial.

Abstract
Background. A multi-centre, four arm trial (the PACE trial) found that rehabilitative cognitive behaviour therapy (CBT) and graded exercise therapy (GET) were more effective treatments for chronic fatigue syndrome than specialist medical care alone (SMC), when each was added to SMC, and more effective than adaptive pacing therapy when added to SMC. In this paper we compared how many participants recovered after each treatment

Methods. We defined recovery operationally using multiple criteria, and compared the proportions of participants meeting each individual criterion as well as two composite criteria, defined as (a) recovery in the context of the trial and (b) clinical recovery from the current episode of the illness, however defined, 52 weeks after randomisation. We used logistic regression modelling to compare treatments.

Results. The percentages (number/total) meeting trial criteria for recovery were 22% (32/143) after CBT, 22% (32/143) after GET, 8% (12/149) after APT, and 7% (11/150) after SMC. Similar proportions met criteria for clinical recovery. The odds ratio (OR, 95% CI) for trial recovery after CBT was 3.36 (1.64, 6.88) and for GET 3.38 (1.65, 6.93), when compared to APT, and after CBT 3.69 (1.77, 7.69) and GET 3.71 (1.78, 7.74), when compared to SMC (p values ≤ 0.001 for all comparisons). There was no significant difference between APT and SMC. Similar proportions recovered in trial subgroups meeting different definitions of the illness.

Conclusions. This study confirms that recovery from CFS is possible, and that CBT and GET are the therapies most likely to lead to recovery.

http://www.eapm2013.com/wp-content/uploads/2013/05/237.doc
Abstract 237

Paul McCrone (presenter), M Sharpe, T Chalder, M Knapp, AL Johnson, KA Goldsmith, PD White

Cost-effectiveness and cost-utility of treatments given in the PACE trial for chronic fatigue syndrome

Abstract
Background. The PACE trial compared the effectiveness of adding adaptive pacing therapy (APT), cognitive behaviour therapy (CBT), or graded exercise therapy (GET), to specialist medical care (SMC) for patients with chronic fatigue syndrome. This paper reports the relative cost-effectiveness of these treatments in terms of quality adjusted life years (QALYs) and improvements in fatigue and physical function.

Methods. Resource use was measured and costs calculated. Healthcare and societal costs (healthcare plus lost production and unpaid informal care) were combined with QALYs gained, and changes in fatigue and disability; incremental cost-effectiveness ratios (ICERs) were computed.

Results. SMC patients had significantly lower healthcare costs than those receiving APT, CBT and GET. If society is willing to value a QALY at £30,000 there is a 62.7% likelihood that CBT is the most cost-effective therapy, a 26.8% likelihood that GET is most cost effective, 2.6% that APT is most cost-effective and 7.9% that SMC alone is most cost-effective. Compared to SMC alone, the incremental healthcare cost per QALY was £18,374 for CBT, £23,615 for GET and £55,235 for APT. From a societal perspective CBT has a 59.5% likelihood of being the most cost-effective, GET 34.8%, APT 0.2% and SMC alone 5.5%. CBT and GET dominated SMC, while APT had a cost per QALY of £127,047. ICERs using reductions in fatigue and disability as outcomes largely mirrored these findings.

Conclusions. Comparing the four treatments using a health care perspective, CBT had the greatest probability of being the most cost-effective followed by GET. APT had a lower probability of being the most cost-effective option than SMC alone. The relative cost-effectiveness was even greater from a societal perspective as additional cost savings due to reduced need for informal care were likely.

http://www.eapm2013.com/wp-content/uploads/2013/05/238.doc

Abstract 238

Mechanisms of change underlying the efficacy of cognitive behaviour therapy for chronic fatigue syndrome: A mediation analysis

Chalder T (Presenter), Goldsmith K, White P, Sharpe M & Pickles A.

Abstract:
TBA

http://www.eapm2013.com/wp-content/uploads/2013/05/239.doc

Abstract 239

What are the lessons for Psychological Medicine from the PACE trial?

Presentation by Michael Sharpe MD

Professor Psychological Medicine

University of Oxford

The PACE trial was a large multi-centre trial comparing three psychologically informed treatments for patients with chronic fatigue syndrome (CFS). The trial found that cognitive behaviour therapy and graded exercise therapy offered a moderate benefit over simply seeing a hospital specialist and also over adaptive pacing therapy. The trial was one of the largest and most rigorous ever conducted in the field of psychological medicine and produced clear findings that will inform treatment of patients with a neglected condition. However, the response to the trial findings has been very varied and sometimes frankly hostile. This presentation will explore the potential reasons for this response and the implications for the practice of psychological medicine.

 

[Dolphin]

http://www.eapm2013.com/wp-content/uploads/2013/05/239.doc

Abstract 239

What are the lessons for Psychological Medicine from the PACE trial?

Presentation by Michael Sharpe MD

Professor Psychological Medicine

University of Oxford

The PACE trial was a large multi-centre trial comparing three psychologically informed treatments for patients with chronic fatigue syndrome (CFS). The trial found that cognitive behaviour therapy and graded exercise therapy offered a moderate benefit over simply seeing a hospital specialist and also over adaptive pacing therapy. The trial was one of the largest and most rigorous ever conducted in the field of psychological medicine and produced clear findings that will inform treatment of patients with a neglected condition. However, the response to the trial findings has been very varied and sometimes frankly hostile. This presentation will explore the potential reasons for this response and the implications for the practice of psychological medicine.

So one of the PACE Trial PIs is going to give very speculative opinions on these issues, but they won't share some concrete data, including data they said they'd publish (in a trial that cost £5m).

 

[Esther12]

I'd love more info on that Sharpe presentation. I wonder if he will focus on 'stigma' and the 'failure to understand how mind and body interact' (the reasons he like to claim he is criticised) or 'failure to release data on outcome measures laid out in protocol' and 'false claims made and left uncorrected in journals and media' (the actual criticisms made of PACE).

 

[Graham]

And in the right corner, in blue, Scientific Reason: in the left corner, in green, The Sharp Presentation. May the best man win.

 

[Dolphin]

What are the lessons for Psychological Medicine from the PACE trial?

Presentation by Michael Sharpe MD

Professor Psychological Medicine

University of Oxford

<snip>
The trial was one of the largest and most rigorous ever conducted in the field of psychological medicine and produced clear findings that will inform treatment of patients with a neglected condition.

No change in 6 minute walking test for CBT over SMC comes to mind. The main clear thing is the differences between subjective and objective outcomes but doubt that's what he's talking about.

The more I think about this, the more it annoys me: he's hardly likely to criticise the trial, how the results were presented, etc. so this is likely to be a completely unbalanced presentation.